510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K822965Substantially Equivalent

Cetus Cmv Iha

Cetus Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822965 is the FDA 510(k) clearance record for CETUS CMV IHA, a class II device, cleared for Cetus Corp. on under FDA product code LJO (Antigen, Iha, Cytomegalovirus). FDA records list one 510(k) clearance for Cetus Corp. As of , FDA records show no recalls naming K822965.

Clearance record

Decision date
Received
(131 days to decision)
Product code
LJO Antigen, Iha, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
Cetus Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LJO

Trailing 12 months

FDA records hold no clearances under product code LJO in the trailing twelve months.

FDA records show no clearances under product code LJO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260